A special review panel has unanimously agreed that no changes need be made to the 2006 Lyme disease treatment guidelines developed by the Infectious Diseases Society of America (IDSA).
The guidelines, voluntarily used by physicians to help them decide what treatments are best and safest for patients, were the subject of an antitrust investigation begun in 2006 by Connecticut Attorney General Richard Blumenthal. Blumenthal examined whether the guidelines’ authors had conflicts of interest and failed to consider divergent medical opinions. IDSA maintains those assertions were unfounded and, as part of an agreement to end the Attorney General’s investigation, voluntarily agreed to a one-time special review of the guidelines by an independent scientific review panel whose members were certified to be free from any conflicts of interest by an independent ombudsman.
Lyme disease is caused by an infection with a type of bacterium called Borrelia burgdorferi, which typically is transmitted by the deer tick. Lyme disease often causes a red, circular rash and muscle and joint aches. A short-course of oral antibiotics remains the standard treatment for patients with Lyme disease, the most common tick-borne illness, which first was discovered in Lyme, Conn.
At issue is the existence of a “chronic” form of Lyme disease and its treatment with long-term antibiotics for months or years. This controversial and costly treatment, which is typically delivered intravenously through a catheter, is advocated by self-described “Lyme literate” physicians.
“IDSA’s primary concern is for the health and safety of patients,” said IDSA president Richard Whitley, MD. “Our goal is to ensure that patients are given treatment that is safe, effective and supported by scientific evidence. Allegations that the 2006 guidelines panelists stood to gain from the recommendations are unfounded. In fact, one could argue the opposite was true, because the panelists recommended short courses of generic drugs.”
To ensure a fair and unbiased review of the 2006 guidelines, IDSA and the Attorney General jointly selected an ombudsman, Howard Brody, MD, PhD, an author and respected medical ethicist at the University of Texas Medical Branch. Brody screened all potential review panel members for conflicts of interest using criteria jointly approved by the Attorney General and the IDSA. The review panel was comprised of nine scientists and physicians from relevant disciplines who had not served on any previous Lyme disease guidelines panel.
The review panel’s work took more than a year to complete, with the group convening 16 times, including at an all-day public hearing in Washington, D.C. More than 150 individuals or organizations submitted evidence and other information including letters, newspaper articles, patient medical records and other materials on Lyme disease and its treatment. Learn more about Lyme disease and the review process.
“This was truly an extraordinary review process,” said Carol J. Baker, MD, who chaired the review panel and is a pediatric infectious diseases specialist at Baylor College of Medicine in Houston. “The final report includes more than 1000 citations, and after thoughtfully and carefully reviewing myriad materials, the panelists feel confident that advice to physicians treating Lyme disease should remain the same as set forth in the 2006 Lyme disease guidelines.”
